HIV InfectionsPhase 2NCT00017992
Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV
A Phase 2 study testing Lopinavir/Ritonavir, Emtricitabine and Stavudine in people with HIV Infections, run by Triangle Pharmaceuticals at 14 sites in 6 countries.
Trial summary
The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Lopinavir/Ritonavir, Emtricitabine and Stavudine
- How many people
- 100 participants
- Where
- 14 sitesin 6 countries
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children may be eligible for this study if they:
- Are at least 3 months old and no older than 17 years of age. This is the age the child needs to be at the time they begin the study.
- Are HIV positive.
- Weigh more than 5.5 pounds. A newborn child must have reached at least 38 weeks of gestation.
- Have or have not taken anti-HIV drugs. Those that have not must have a viral load between 5,000 and 500,000 copies/ml at screening. Those that have must have been taking anti-HIV drugs, including lamivudine, for at least 3 months and have a viral load of no more than 400 copies/ml at screening.
- Have a CD4 count of more than 200 cells/mm3.
- Have written consent from parent or guardian.
- Are willing to use effective birth control during the study and for 1 month after the last dose of emtricitabine, if sexually active.
Who cannot join
- Children will not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Cannot follow the visit or dosing schedule or are not available for 1 year.
- Have taken experimental drugs or vaccines (except for emivirine and experimental forms of approved drugs) within 30 days of study start.
- Have nerve damage in their arms or legs.
- Have trouble eating or taking drugs.
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- Have serious diarrhea within 30 days before study entry.
- Have had any serious illness within 30 days of study screening. Any treatment must have been finished 14 days before study entry.
- Have had an AIDS-related (opportunistic) disease within 12 months of screening.
- Are being treated for tuberculosis.
- Have had pancreatitis.
- Require certain drugs.
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
United States8 sites
- Active, not recruiting
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
- Active, not recruiting
USC School of Medicine / LA County Med Ctr
Los Angeles, California, 90033
- Active, not recruiting
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
- Active, not recruiting
Univ of Miami
Miami, Florida, 331016960
- Active, not recruiting
New York Hosp / Cornell Med Ctr
New York, New York, 10021
- Active, not recruiting
St Luke's - Roosevelt Hosp Ctr
New York, New York, 10025
- Active, not recruiting
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
- Active, not recruiting
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461
South Africa2 sites, 2 recruiting
- Recruiting
Perinatal HIV Research UNIT
Diepkloof
Dr. Avy Violari, 011+27 11 989 9700, violari@mweb.co.za
- Recruiting
Infectious Diseases Clinincal Trial Unit
Gaunteng
Pauline Francesca Conradie, 011+ 27 11 717 2810, francesca_conradie@witshealth.co.za
Mexico1 site
- Active, not recruiting
Instituto Mexicano de Investigacion Clinica
Colonia Roma
Puerto Rico1 site
- Active, not recruiting
Univ of Puerto Rico / Med Science Campus
San Juan, 00936
About this study
Official title: An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV-Infected Pediatric Patients
The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.
Read the detailed description
Children are placed into 1 of 4 treatment groups based on age: Group 1, 3 months to 24 months; Group 2, 25 months to 6 years; Group 3, 7 years to 12 years; Group 4, 13 years to 17 years. They receive baseline evaluations. Antiretroviral-naive patients receive emtricitabine plus stavudine plus lopinavir/ritonavir. Antiretroviral-experienced patients replace lamivudine with emtricitabine. Patients return to the clinic for follow-up visits at Weeks 2 and 4 and then every 4 weeks until Week 48. Safety is evaluated using adverse events, which are reviewed at every clinic visit. Clinical laboratory data and full-profile pharmacokinetics of emtricitabine are evaluated at some visits. After the Week 48 study evaluations are completed, individual patients may continue to receive study medication (as provided by the sponsor) until commercially available, if certain criteria are met.
- Conditions
- HIV Infections
- Being tested
- Lopinavir/Ritonavir, Emtricitabine, Stavudine
- Keywords
- HIV-1, Drug Administration Schedule, Stavudine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Pharmacokinetics, ABT 378, emtricitabine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir/RitonavirDrug
EmtricitabineDrug
StavudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Triangle Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017992
- Sponsor's protocol ID
- 298D
- Other IDs
- FTC-203
- Status last verified
- Mar 2003
- First submitted
- 23 Jun 2001
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV-Infected Pediatric Patients
- ClinicalTrials.gov ID
- NCT00017992
- Acronym / sponsor ID
- 298D
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Administration Schedule, Stavudine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Triangle PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.
Detailed description
Children are placed into 1 of 4 treatment groups based on age: Group 1, 3 months to 24 months; Group 2, 25 months to 6 years; Group 3, 7 years to 12 years; Group 4, 13 years to 17 years. They receive baseline evaluations. Antiretroviral-naive patients receive emtricitabine plus stavudine plus lopinavir/ritonavir. Antiretroviral-experienced patients replace lamivudine with emtricitabine. Patients return to the clinic for follow-up visits at Weeks 2 and 4 and then every 4 weeks until Week 48. Safety is evaluated using adverse events, which are reviewed at every clinic visit. Clinical laboratory data and full-profile pharmacokinetics of emtricitabine are evaluated at some visits. After the Week 48 study evaluations are completed, individual patients may continue to receive study medication (as provided by the sponsor) until commercially available, if certain criteria are met.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Are at least 3 months old and no older than 17 years of age. This is the age the child needs to be at the time they begin the study.
- Are HIV positive.
- Weigh more than 5.5 pounds. A newborn child must have reached at least 38 weeks of gestation.
- Have or have not taken anti-HIV drugs. Those that have not must have a viral load between 5,000 and 500,000 copies/ml at screening. Those that have must have been taking anti-HIV drugs, including lamivudine, for at least 3 months and have a viral load of no more than 400 copies/ml at screening.
- Have a CD4 count of more than 200 cells/mm3.
Key exclusion criteria (12 listed)
- Are pregnant or breast-feeding.
- Cannot follow the visit or dosing schedule or are not available for 1 year.
- Have taken experimental drugs or vaccines (except for emivirine and experimental forms of approved drugs) within 30 days of study start.
- Have nerve damage in their arms or legs.
- Have trouble eating or taking drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lopinavir/Ritonavir | Drug | – |
| Emtricitabine | Drug | – |
| Stavudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Infectious Diseases Clinincal Trial Unit
Gaunteng, South Africa
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lopinavir/Ritonavir, Emtricitabine and Stavudine in people with HIV Infections, run by Triangle Pharmaceuticals at 14 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, South Africa, Argentina, Mexico, Panama and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.